76054 Federal Register / Vol. 70, No.
245 / Thursday, December 22, 2005 / Notices
Trans #
20060182 ......................... ValueAct Capital Master Fund, L.P ...
20060201 ......................... MediaNews Group, Inc. .....................
20060221 ......................... Autonomy Corporation plc .................
20060196 ......................... Johnson & Johnson ...........................
FOR FURTHER INFORMATION CONTACT:
Sandra M. Peay, Contact Representative
or Renee Hallman, Contact
Representative. Federal Trade
Commission, Premerger Notification
Office, Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–24357 Filed 12–21–05; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Annual Long-
Term Care Ombudsman Report and
Instructions for Older Americans Act
Title VII
AGENCY: Administration on Aging, HHS.
ACTION: Notice
SUMMARY: The Administration on Aging
(AoA) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
agency. Under the Paperwork Reduction
Act of 1995 (the PRA), Federal agencies
are required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to State
Annual Long-Term Care Ombudsman
Report and instructions for Older
Americans Act Title VII.
DATES: Submit written or electronic
cchase on PROD1PC60 with NOTICES
comments on the collection of
information by February 21, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: sue.wheaton@aoa.gov.
VerDate Aug<31>2005 16:55 Dec 21, 2005 Jkt 208001
Acquiring
The Reynolds and Reynolds Com-
pany.
Gannett Co., Inc ................................
Verity, Inc ..........................................
Transactions Granted Early Termination—12/01/2005
Biovail Corporation ............................
Submit written comments on the
collection of information to:
Administration on Aging, Washington,
DC 20201. Attention: Sue Wheaton
FOR FURTHER INFORMATION CONTACT: Sue
Wheaton, by telephone: (202) 357–3587
or by e-mail: sue.wheaton@aoa.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, AoA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
when appropriate, and other forms of
information technology.
Under section 712(c), section
712(h)(1) and section 712(h)(B) of the
Older Americans Act, as amended,
states are required to provide
information on ombudsmen activities to
PO 00000 Frm 00036 Fmt 4703 Sfmt 4703
Acquired Entities
The Reynolds and Reynolds Com-
pany.
Texas-New Mexico Newspapers
Partnership.
Verity, Inc.
Biovail Laboratories International
SRL.
AoA, which AoA is then required to
present to Congress. The reporting
system, the National Ombudsman
Reporting System (NORS), was
developed in response to these
directives and other needs pertaining to
the Long Term Care Ombudsman
Program and approved by the Office of
Management and Budget for use for the
first time in FY 1995–96; it was
extended a second time with slight
modifications for use in FY 1997–2001
and extended for the third time with no
change for use from FY 2002–2006. This
current (fourth) request is to extend,
with modifications, use of the existing
State Annual Long-Term Care
Ombudsman Report (and Instructions)
from Older Americans Act Title VII
grantees. The details of these proposed
changes are contained on the AoA Web
site at: http://www.aoa.gov/prof/
aoaprog/elder_rights/LTCombudsman/
NORS/nors_form_instructions.asp. AoA
estimates the burden of this collection
of information as follows:
Approximately one and one-half hour
per respondent with 52 State Agencies
on Aging responding annually.
Dated: December 19, 2005.
Josefina G. Carbonell,
Assistant Secretary for Aging.
[FR Doc. 05–24356 Filed 12–21–05; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0486]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Public Health
Notification (formerly known as Safety
Alert/Public Health Advisory)
Readership Survey
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
E:\FR\FM\22DEN1.SGM 22DEN1
 Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA Public Health Notification
(formerly known as Safety Alert/Public
Health Advisory) Readership Survey.
DATES: Submit written or electronic
comments on the collection of
information by February 21, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: http://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60–day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of respondents
cchase on PROD1PC60 with NOTICES
308
1There are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005 16:55 Dec 21, 2005 Jkt 208001
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
FDA Public Health Notification
(formerly known as Safety Alert/Public
Health Advisory) Readership Survey
(OMB Control Number 0910–0341)—
Extension
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 375(b)) authorizes FDA to
disseminate information concerning
imminent danger to public health by
any regulated product. The Center for
Devices and Radiological Health (CDRH)
communicates these risks to user
communities through two publications:
(1) The Public Health Notification
(PHN) and (2) the Preliminary Public
Health Notification (PPHN). The PHN is
published when CDRH has information
or a message to convey to health care
practitioners that they would want to
know in order to make informed clinical
decisions about the use of a device or
device type, and that information may
not be readily available to the affected
target audience in the health care
community, and CDRH can make
recommendations that will help the
health care practitioner mitigate or
avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners that they
would want to know in order to make
informed clinical decisions about the
Annual Frequency
per response
3 924
PO 00000 Frm 00037 Fmt 4703 Sfmt 4703
76055
use of a device or device type. However,
two additional conditions exist that
make the use of this type of notification
preferable. First, CDRH’s understanding
of the problem, its cause(s), and the
scope of the risk is still evolving, and in
order to minimize the risk, the center
believes that health care practitioners
need the information they have,
however incomplete, as soon as
possible. Second, the problem is being
actively investigated by the center, the
industry, another agency or some other
reliable entity, so that the center expects
to be able to update the PPHN when
definitive new information becomes
available.
Notifications are sent to organizations
affected by the risks discussed in the
notification such as hospitals, nursing
homes, hospices, home health care
agencies, retail pharmacies, and other
health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
regulated products, CDRH determines
when to publish notifications.
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C. 300u(a)(4)
authorizes FDA to conduct research
relating to health information. FDA
seeks to evaluate the clarity, timeliness,
and impact of safety alerts and public
health advisories by surveying a sample
of recipients. Subjects will receive a
questionnaire to be completed and
returned to FDA. The information to be
collected will address how clearly
notifications for reducing risk are
explained, the timeliness of the
information, and whether the reader has
taken any action to eliminate or reduce
risk as a result of information in the
alert. Subjects will also be asked
whether they wish to receive future
notifications electronically, as well as
how the PHN program might be
improved.
The information collected will be
used to shape FDA’s editorial policy for
the PHN and PPHN. Understanding how
target audiences view these publications
will aid in deciding what changes
should be considered in their content,
format, and method of dissemination.
FDA estimates the burden of this
collection of information as follows:
Total Annual Hours per
Total hours
responses response
.17 157
E:\FR\FM\22DEN1.SGM 22DEN1
 76056 Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices
Based on the history of the PHN
program, it is estimated that an average
of three collections will be conducted a
year. The total burden of response time
is estimated at 10 minutes per survey.
This was derived by CDRH staff
completing the survey and through
discussions with the contacts in trade
organizations.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7642 Filed 12–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0274]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary Hazard
Analysis and Critical Control Point
Manuals for Operators and Regulators
of Retail and Food Service
Establishments
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 23,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
cchase on PROD1PC60 with NOTICES
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
VerDate Aug<31>2005 17:05 Dec 21, 2005 Jkt 208001
has submitted the following proposed
collection of information to OMB for
review and clearance.
Voluntary Hazard Analysis and Critical
Control Point (HACCP) Manuals for
Operators and Regulators of Retail and
Food Service Establishments
The draft Operator’s Manual contains
information and recommendations for
operators of retail and foodservice
establishments who wish to develop
and implement a voluntary food safety
management system based on HACCP
principles. Operators may decide to
incorporate some or all of the principles
presented in the draft manual into their
existing food safety management
systems. The recordkeeping practices
discussed in the draft manual are
voluntary and may include
documenting certain activities, such as
monitoring and verification, which the
operator may or may not deem
necessary to ensure food safety. The
draft manual includes optional
worksheets to assist operators in
developing and validating a voluntary
food safety management system.
The draft Regulator’s Manual contains
recommendations for State, local, and
tribal regulators on conducting risk-
based inspections of retail and
foodservice establishments, including
recommendations about recordkeeping
practices that can assist operators in
preventing foodborne illness. These
recommendations may lead to voluntary
actions by operators based on
consultation with regulators. For
example, an operator may develop a risk
control plan as an intervention strategy
for controlling specific out-of-control
foodborne illness risk factors identified
during an inspection. Further, the draft
manual contains recommendations to
assist regulators when evaluating
voluntary food safety management
systems in retail and foodservice
establishments. Such evaluations
typically consist of the following two
components: Validation (assessing
whether the establishment’s voluntary
food safety management system is
adequate to control food safety hazards)
and verification (assessing whether the
establishment is following its voluntary
food safety management system). The
draft manual includes a sample
‘‘Verification Inspection Checklist’’ to
assist regulators when conducting
verification inspections of
establishments with voluntary food
safety management systems.
PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM
Types of operator records discussed
in the manuals and listed in the
following burden estimates include:
Food safety management systems (plans
that delineate the formal procedures to
follow to control all food safety hazards
in an operation); risk control plans
(HACCP-based, goal-oriented plans for
achieving active managerial control over
specific out-of-control foodborne illness
risk factors); hazard analysis (written
assessment of the significant food safety
hazards associated with foods prepared
in the establishment); prerequisite
programs (written policies or
procedures, including but not limited
to, standard operating procedures,
training protocols, and buyer
specifications that address maintenance
of basic operational and sanitation
conditions); monitoring (records
showing the observations or
measurements that are made to help
determine if critical limits are being met
and maintained); corrective action
(records indicating the activities that are
completed whenever a critical limit is
not met); ongoing verification (records
showing the procedures that are
followed to ensure that monitoring and
other functions of the food safety
management system are being
implemented properly); and validation
(records indicating that scientific and
technical information is collected and
evaluated to determine if the food safety
management system, when properly
implemented, effectively controls the
hazards).
All recommendations in both manuals
are voluntary. For simplicity and to
avoid duplicate estimates for operator
recordkeeping practices that are
discussed in both manuals, the burden
for all collection of information
recommendations for retail and
foodservice operators are estimated
together in table 1 of this document,
regardless of the manual in which they
appear. Collection of information
recommendations for regulators in the
Regulator’s Manual are listed separately
in table 2 of this document.
The likely respondents to this
collection of information are operators
and regulators of retail and foodservice
establishments.
In the Federal Register of July 21,
2005 (70 FR 42072), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of the
collection of information as follows:
22DEN1